QA Processes. Philip DaCosta BSCP QA Lead, Yorkshire & the Humber September 2013

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1 QA Processes Philip DaCosta BSCP QA Lead, Yorkshire & the Humber September 2013

2 Standards QA visits Dashboards

3 BCSP standards Standards for Organisation Service delivery Reporting Data quality Audit and quality measures Linked in with QA process

4 Pathology Standards - 1 Guidance: Section 1 - Leadership Each screening centre must have an identified Lead Pathologist. The duties should be agreed with the Clinical Director of the Screening Centre and the work included in the Lead Pathologist s job plan. Where screening centre pathology is reported by more than one pathology laboratory, each laboratory must identify a Site Pathology Lead to work with the Lead Pathologist of the centre in the co-ordination of service delivery and the maintenance of standards. There should be a nominated deputy for lead roles. Section 2 - Workload All BCSP cases should be clearly identified and easily accessible on local pathology IT systems, to facilitate activity monitoring, audit and quality assurance (QA).. Section 3 - Staffing and accreditation The histopathology laboratory should hold accreditation from CPA (UK) Ltd or other accreditation service to ISO standards or equivalent. Examination and reporting of screening cases must be undertaken only by suitably trained medical staff and biomedical scientist staff. All pathologists reporting specimens for the screening programme must a. have BCSP work included in their Job Plan so as to accommodate educational, audit, QA and other supporting activities. b. participate in the national BCSP External Quality Assurance (EQA) scheme (see section 7) c. participate in appropriate CPD activities (see section 8) d. participate in audit of the quality and timeliness of their work for the BCSP (see section 7) Section 4 - Laboratory processes, including risk management Histopathology reporting must be in accordance with guidelines of the RCPath/ BCSP guidance relating to colorectal pathology, applicable to the specimen type being reported. Histopathology reports for at least 90% of specimens submitted from colonoscopy should be authorised and relayed to referrer within 7 calendar days of receipt of the specimen in the laboratory. Each centre must establish a protocol for the referral for specialist opinion, when there is uncertainty over a histological diagnosis. Opinions may be obtained from: A second local pathologist. A regional specialist Gastro-intestinal Pathologist or reference panel. The Expert Board, established and funded by BCSP, especially for difficult polyps. Newly appointed screening pathologists (or those returning after prolonged periods of absence) must be mentored and supervised by the site lead pathologist to ensure that they are properly inducted into the local BCSP processes, and that there is compliance with national guidelines and local operational procedures. The site lead should confirm competence of the individual to undertake the task of screening pathologist to the Clinical Director of the Screening Centre. All pt1 polyp cancers must be double reported i.e. reviewed and the diagnosis agreed by at least two screening pathologists. The issued report should contain a statement to this effect. Laboratories should agree a procedure with the Screening Centre for the management of cases where there is a change of diagnosis.

5 Pathology Standards - 2 Section 5 - Communication All cancer cases generated by the BCSP must be discussed in a colorectal cancer multidisciplinary team meeting (MDTM) to plan future management. Reports of unexpected cancers diagnosed by histopathology without prior indication must be conveyed to the Specialist Screening Practitioner within 24 hours of confirmation of histology so that appropriate patient counselling and investigations can be instituted. There should be good levels of communication between the screening centre staff, including the Lead Pathologist of the centre. Section 6 - Data collection Histopathology for the BCSP should contain all relevant information in an easily retrievable form, for example by the use of standardised proformas or template reports Histopathology reports generated freehand or by cancer dataset software should include all key items of the relevant RCPath/BCSP dataset for polyps, polyp cancers, cancer local excisions and cancer resections. Section 7 - QA and audit The lead pathologist for the screening centre should ensure that all pathologists reporting specimens for the screening programme participate in the national BCSP EQA scheme. The lead pathologist for each centre should audit the pathology quality indicators against the screening programme benchmarks. The lead pathologist for each centre and the site leads for reporting departments should participate in the quality assurance processes organised by the relevant regional BCSP Quality Assurance team. The laboratory should demonstrate overall satisfactory performance in an accredited technical quality assessment scheme (TQAS). Regular audit or discussions among relevant professionals should be held in each laboratory to include the discussion of interesting and problem cases. Section 8 - Training and CPD All pathologists involved in reporting of BCSP cases must participate in regular training and QA activities provided by or recognised by the screening programme. (It is recommended that individuals attend regional or national education and QA meetings at least twice in each three year QA cycle) Section 9 - Quality markers The pathology data for each centre should be bench-marked against national data and the quality standards recommended within the relevant RCPath/BCSP guidance on the reporting of screening pathology and colorectal cancers.

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7 What is changing & why? Induction and mentoring of new & returning pathologists Change of diagnosis SOP Educational requirements revised Selection of cases for review

8 QA Visits Three yearly, organised by QARC Centre based and multi-disciplinary Pre-visit set-up meetings Pre-visit questionnaires for each professional group Review of sample of cases 1-2 day visits with detailed discussions with leads, open meetings with professional groups, and visits to facilities Review of data and audits

9 What does the BCSP pathologist need to do? Follow BCSP/RCPath guidelines for examination & reporting BCSP cases CPD EQA Audit Job-plan

10 Audits Service turn around times for BCSP specimens Polyp reporting measurement, low/highgrade dysplasia, serrated lesions Cancer reporting RCPath quality indicators (node harvest, EMVI and serosal involvement rates and stage distribution) * Much of these data are now available through the BCSS dashboard

11 RCPath Colorectal Cancer Minimum Dataset, 2nd revision (2007) G T Williams, P Quirke, N A Shepherd It is therefore recommended that pathologists audit their reports at regular intervals (perhaps yearly) to ensure that their overall results are not significantly different from what might expected. Three standards are recommended for this purpose, namely that in a series of at least 50 resection specimens: a) the median number of lymph nodes examined is 12 b) the frequency of serosal involvement is at least 20% for colonic cancers and 10% for rectal cancers c) the frequency of extramural vascular invasion is at least 25% We believe there is a reasonable evidence base to suggest that the mean harvest of lymph nodes should be at least 12 but accept that there is less evidence base for the two other outcome measures. Nevertheless, we believe that this is a start at setting such standards and evidence will follow to allow us to adjust these levels in the future.

12 Median lymph node yield Lymph nodes by year Operation year Courtesy of Professor P Quirke and NYCRIS

13 Nodes No

14 % EMVI

15 % LPI Colon

16 Issues arising from QA reviews Measurement of polyps Application of guidance (dysplasia, villousity) Dataset items (polyps, especially size) (EQA participation & access) (CPD & educational events) (BCSP work mentioned in job-plans)

17 Positives Contact with the pathology teams Assurance Education Feedback Improvements

18 Negatives Hard work all round Overkill Some aspects tedious

19 CQC s operating model Intelligent Monitoring Data & evidence Information from people Expert Inspection Expert teams Thorough Talking to people & staff Quality of Care Safe? Effective? Caring? Responsive? Well-led?

20 OBIEE PATHOLOGY DASHBOARD

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30 QUESTIONS?